Cardiovascular DiseasesRESILIENCENCT04614428
Improving Outcomes in Patients With Cardiovascular Seasonality
A study testing RESILIENCE Program in people with Cardiovascular Diseases, run by Sheila Patel at 1 site in Australia.
Trial summary
Despite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are "resistant" to such programs. These "seasonal frequent flyers" routinely overwhelm hospital services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- RESILIENCE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Nov 2020to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual aged 18 years and over.
- Admitted to hospital due to a medical emergency for any reason but with a chronic form of heart disease (i.e. including. coronary artery disease, atrial fibrillation and/or heart failure) requiring treatment
- Multimorbidity (defined as two or more chronic conditions requiring active treatment/management).
- A planned discharge to home within a 10km radius of the hospital.
Who cannot join
- Living in residential aged care
- Terminal illness and/or unable to give informed consent
- Died during index admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored, Interventional Health Care Program Designed to Address Seasonal Vulnerability in Patients With Chronic Heart Disease and Multimorbidity: the REsilience to Seasonal ILlness and Increased Emergency admissioNs CarE (RESILIENCE) Trial
Despite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are "resistant" to such programs. These "seasonal frequent flyers" routinely overwhelm hospital services. The investigators have identified vulnerability to provocation of seasonal and acute weather changes ("seasonality") as a major driver of preventable/costly hospitalisations in typically older patients with heart disease and multimorbidity subject to gold-standard care. From this research the investigators developed the RESILIENCE Program which is tailored to each person and designed to assist the participants to become more "resilient" to changes in the weather.
The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an individually tailored, interventional health care program designed to address the debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of individuals admitted to hospital with chronic heart disease and multimorbidity.
Read the detailed description
After informed written consent, a total of 203 participants (of an initially planned 300 participants prior to the COVID pandemic) had comprehensive sociodemographic and clinical profiling to establish extent of multi-morbidity. Baseline demographic, lifestyle and medical history profiling were also completed - including anthropometric measurements, and blood pressure, handgrip strength test and sit-stand tests. The Montreal Cognitive Assessment, depression, anxiety and quality of life questionnaires were also applied. Blood biochemistry will be assessed for vitamin D, blood counts, thyroid and renal function, hemoglobin and glycated hemoglobin levels.
After the initial profiling, 203 participants were randomized to standard care or the RESILIENCE Program group and discharged alive to home.
In addition to the standard care participants would normally receive, the one in two participants assigned to the RESILIENCE Program group will receive a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective. These will include a combination of strategies designed to promote seasonal resilience.
Specifically, this will include:
- Profiling of the participants seasonal vulnerability: prior to hospital discharge, participants will be clinically profiled and then fitted with an physiological monitor (to measure heart rate, physical activity levels) at the point of hospital discharge.
- Within 7-14 days after discharge a 60-80-minute home visit will be conducted by a dedicated RESILIENCE Nurse to assess:
- Physiological Status: The physiological monitor will be collected for analysis at this visit and blood pressure will be measured.
- Environment: A formal home environment assessment including presence/type of heating and/or cooling equipment, air quality and any other factors that might contribute to seasonal instability (e.g. lack of home insulation). Indoor versus outdoor temperature and humidity will also be measured.
- Behaviour: Participants will be asked to describe the adaptive changes they make to activity levels, diet, clothing and heating/cooling behaviours during winter versus summer and acute weather events; with an immediate assessment relevant to ambient weather conditions.
- Modulating Factors: The (socio-economic) capacity for the participant/family to apply resources/funds to maintain thermoregulatory control (including clothing choices and ability to pay power bills) throughout the year will be assessed; alongside those personal factors/decisions that potentially determine how they prioritize other forms of expenditure.
- Participants with the capacity and/or preference for videoconferencing will be offered "virtual/remote" attendance or a standard outpatient clinic appointment at the Austin Hospital RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience. The clinic appointments will occur with the individual at 21 days, 6 months and 12 months post hospital discharge.
At 12 months, the comprehensive socio-demographic and clinical profiling will be repeated in the RESILIENCE Program group.
Due to the impact of the COVID epidemic (with extensive lockdowns in Melbourne, Victoria and clinical restrictions at the Austin Hospital), a reduced study cohort was recruited (203 of planned 300 eligible and randomised participants) with follow-up extended beyond 12 months to (partially) restore study power to examine the potential impact of the study intervention on the same health outcomes.
- Conditions
- Cardiovascular Diseases
- Being tested
- RESILIENCE Program
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESILIENCE ProgramBehavioural
In addition to the standard care participants would normally receive (including exposure to any standard hospital avoidance programs), the 150 participants assigned to the RESILIENCE Program group will receive a combination of strategies designed to promote seasonal resilience.
This includes profiling of seasonal vulnerability; a 60-80 minute home visit by the RESILIENCE Nurse to assess physiological status, behavioural adaptations, environment, and modulating factors; a dedicated RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience and; a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | Participants will receive the standard care provided by their institution. |
| RESILIENCE Program group | Active comparator | Participants will receive the RESILIENCE Program on top of the standard care provided by their institution. Receives: Behavioral: RESILIENCE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days-alive-out-of-hospital (DAOH)
Defined as the proportion of maximal days follow-up where the study participant was not admitted to hospital and alive. DAOH data will be collected from hospital records. During minimum 12-month follow-up, the pre-specified threshold for a clinically significant effect in favour of the RESILIENCE Program is a 10% increase in DOAH compared to "standard care".
Measured: 12-months (minimum) post randomisation to study census (July 2023)
Secondary outcomes (3)
Overall pattern of hospitalization
Frequency and causes of unplanned hospitalization plus Emergency Service and out-patient visits and related bed-days will be determined from hospital medical records.
Measured: 12-months (minimum) post randomisation to study census
Number of community care visits
Including visits to the General Practitioner, pharmacist consultations, allied health services, supported-care and pharmacotherapy determined through the RESILIENCE Clinic.
Measured: 12-months (minimum) post randomisation to study census
Healthcare costs
Healthcare costs assessed for extending days-alive-out-of-hospital, transport and other costs due to clinic attendance as well as co-payments for clinic visits and drug therapy.
All expenditure will be standardized for the reporting year and an extrapolation of the potential impact of the RESILIENCE Program from the perspective of the Australian health care system will be made. QALYs will be calculated from survival and the AQoL-8D as the primary outcome for cost-utility analysis.
Measured: 12-months (minimum) post randomisation to study census
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start25 Nov 2020
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised control trial of two parallel groups; 1. Standard Care 2. Standard Care + RESILIENCE Program
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheila Patel
- Sponsor type
- Other government
- Collaborators
- University of Melbourne
- Responsible party
- Sponsor-investigator, Sheila Patel, Austin Health
- Investigators
- Louise M Burrell, MD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614428
- Sponsor's protocol ID
- CT19026
- Acronym
- RESILIENCE
- Status last verified
- Mar 2024
- First submitted
- 29 Oct 2020
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the published results, may be shared on request by the RESILIENCE TRIAL Investigators at the completion of the trial and reporting of the endpoints.
Publications
Stewart S, Patel SK, Lancefield TF, Sampaio Rodrigues T, Doumtsis N, Moini N, Harley A, Vaughan-Fowler ER, Chan YK, Chen A, Chye D, Liew DF, McMaster C, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Promoting resilience to weather-related and seasonal provocations to health in people with multimorbid heart disease: a prospective pragmatic, randomised trial. Med J Aust. 2025 Jul 21;223(2):77-84. doi: 10.5694/mja2.52699. Epub 2025 Jun 24.
PubMed 40556316Stewart S, Patel SK, Lancefield TF, Rodrigues TS, Doumtsis N, Jess A, Vaughan-Fowler ER, Chan YK, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Vulnerability to environmental and climatic health provocations among women and men hospitalized with chronic heart disease: insights from the RESILIENCE TRIAL cohort. Eur J Cardiovasc Nurs. 2024 Apr 12;23(3):278-286. doi: 10.1093/eurjcn/zvad076.
PubMed 37625011
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored, Interventional Health Care Program Designed to Address Seasonal Vulnerability in Patients With Chronic Heart Disease and Multimorbidity: the REsilience to Seasonal ILlness and Increased Emergency admissioNs CarE (RESILIENCE) Trial
- ClinicalTrials.gov ID
- NCT04614428
- Acronym / sponsor ID
- RESILIENCE / CT19026
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Sheila PatelOther government
- Collaborators
- University of Melbourne
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are "resistant" to such programs. These "seasonal frequent flyers" routinely overwhelm hospital services. The investigators have identified vulnerability to provocation of seasonal and acute weather changes ("seasonality") as a major driver of preventable/costly hospitalisations in typically older patients with heart disease and multimorbidity subject to gold-standard care. From this research the investigators developed the RESILIENCE Program which is tailored to each person and designed to assist the participants to become more "resilient" to changes in the weather.
The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an individually tailored, interventional health care program designed to address the debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of individuals admitted to hospital with chronic heart disease and multimorbidity.
Detailed description
After informed written consent, a total of 203 participants (of an initially planned 300 participants prior to the COVID pandemic) had comprehensive sociodemographic and clinical profiling to establish extent of multi-morbidity. Baseline demographic, lifestyle and medical history profiling were also completed - including anthropometric measurements, and blood pressure, handgrip strength test and sit-stand tests. The Montreal Cognitive Assessment, depression, anxiety and quality of life questionnaires were also applied. Blood biochemistry will be assessed for vitamin D, blood counts, thyroid and renal function, hemoglobin and glycated hemoglobin levels.
After the initial profiling, 203 participants were randomized to standard care or the RESILIENCE Program group and discharged alive to home.
In addition to the standard care participants would normally receive, the one in two participants assigned to the RESILIENCE Program group will receive a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective. These will include a combination of strategies designed to promote seasonal resilience.
Specifically, this will include:
- Profiling of the participants seasonal vulnerability: prior to hospital discharge, participants will be clinically profiled and then fitted with an physiological monitor (to measure heart rate, physical activity levels) at the point of hospital discharge.
- Within 7-14 days after discharge a 60-80-minute home visit will be conducted by a dedicated RESILIENCE Nurse to assess:
- Physiological Status: The physiological monitor will be collected for analysis at this visit and blood pressure will be measured.
- Environment: A formal home environment assessment including presence/type of heating and/or cooling equipment, air quality and any other factors that might contribute to seasonal instability (e.g. lack of home insulation). Indoor versus outdoor temperature and humidity will also be measured.
- Behaviour: Participants will be asked to describe the adaptive changes they make to activity levels, diet, clothing and heating/cooling behaviours during winter versus summer and acute weather events; with an immediate assessment relevant to ambient weather conditions.
- Modulating Factors: The (socio-economic) capacity for the participant/family to apply resources/funds to maintain thermoregulatory control (including clothing choices and ability to pay power bills) throughout the year will be assessed; alongside those personal factors/decisions that potentially determine how they prioritize other forms of expenditure.
- Participants with the capacity and/or preference for videoconferencing will be offered "virtual/remote" attendance or a standard outpatient clinic appointment at the Austin Hospital RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience. The clinic appointments will occur with the individual at 21 days, 6 months and 12 months post hospital discharge.
At 12 months, the comprehensive socio-demographic and clinical profiling will be repeated in the RESILIENCE Program group.
Due to the impact of the COVID epidemic (with extensive lockdowns in Melbourne, Victoria and clinical restrictions at the Austin Hospital), a reduced study cohort was recruited (203 of planned 300 eligible and randomised participants) with follow-up extended beyond 12 months to (partially) restore study power to examine the potential impact of the study intervention on the same health outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised control trial of two parallel groups; 1. Standard Care 2. Standard Care + RESILIENCE Program
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –Participants will receive the standard care provided by their institution. |
| RESILIENCE Program group | Active comparator | Behavioral: RESILIENCE ProgramParticipants will receive the RESILIENCE Program on top of the standard care provided by their institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individual aged 18 years and over.
- Admitted to hospital due to a medical emergency for any reason but with a chronic form of heart disease (i.e. including. coronary artery disease, atrial fibrillation and/or heart failure) requiring treatment
- Multimorbidity (defined as two or more chronic conditions requiring active treatment/management).
- A planned discharge to home within a 10km radius of the hospital.
Key exclusion criteria (3 listed)
- Living in residential aged care
- Terminal illness and/or unable to give informed consent
- Died during index admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESILIENCE ProgramIn addition to the standard care participants would normally receive (including exposure to any standard hospital avoidance programs), the 150 participants assigned to the RESILIENCE Program group will receive a combination of strategies designed to promote seasonal resilience. This includes profiling of seasonal vulnerability; a 60-80 minute home visit by the RESILIENCE Nurse to assess physiological status, behavioural adaptations, environment, and modulating factors; a dedicated RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience and; a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective. | Behavioural | RESILIENCE Program group |
Primary outcome
Days-alive-out-of-hospital (DAOH)
Time frame: 12-months (minimum) post randomisation to study census (July 2023)
Defined as the proportion of maximal days follow-up where the study participant was not admitted to hospital and alive. DAOH data will be collected from hospital records. During minimum 12-month follow-up, the pre-specified threshold for a clinically significant effect in favour of the RESILIENCE Program is a 10% increase in DOAH compared to "standard care".
3 secondary outcomes
Overall pattern of hospitalization
Time frame: 12-months (minimum) post randomisation to study census
Number of community care visits
Time frame: 12-months (minimum) post randomisation to study census
Healthcare costs
Time frame: 12-months (minimum) post randomisation to study census
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Derived from this study: PubMed 40556316Stewart S, Patel SK, Lancefield TF, Sampaio Rodrigues T, Doumtsis N, Moini N, Harley A, Vaughan-Fowler ER, Chan YK, Chen A, Chye D, Liew DF, McMaster C, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Promoting resilience to weather-related and seasonal provocations to health in people with multimorbid heart disease: a prospective pragmatic, randomised trial. Med J Aust. 2025 Jul 21;223(2):77-84. doi: 10.5694/mja2.52699. Epub 2025 Jun 24.
- Derived from this study: PubMed 37625011Stewart S, Patel SK, Lancefield TF, Rodrigues TS, Doumtsis N, Jess A, Vaughan-Fowler ER, Chan YK, Ramchand J, Yates PA, Kwong JC, McDonald CF, Burrell LM. Vulnerability to environmental and climatic health provocations among women and men hospitalized with chronic heart disease: insights from the RESILIENCE TRIAL cohort. Eur J Cardiovasc Nurs. 2024 Apr 12;23(3):278-286. doi: 10.1093/eurjcn/zvad076.
- Individual participant dataSharing planned: Yes. Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences. Individual participant data that underlie the published results, may be shared on request by the RESILIENCE TRIAL Investigators at the completion of the trial and reporting of the endpoints.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise M Burrell, MD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESILIENCE Program in people with Cardiovascular Diseases, run by Sheila Patel at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days-alive-out-of-hospital (DAOH) (time frame: 12-months (minimum) post randomisation to study census (July 2023)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614428, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.